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Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
Date:6/19/2013

ll survival.

The study enrolled patients with a confirmed diagnosis of relapsed or refractory CLL or small lymphocytic lymphoma (a disease that mirrors the symptoms and progression of CLL) at eight sites in the U.S. Patients who participated in the study had a median of four prior therapies and 65 percent of the patients had advanced disease. Twenty-eight CLL patients had del17p, a genetic mutation associated with a poor prognosis.

About CLL
CLL is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), specifically the B-cells. CLL is the most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the US. It is a chronic disease of the elderly with an average survival of about five years after diagnosis. Patients commonly receive multiple lines of treatment over the course of their disease.

In CLL the genetic mutation del17p occurs when the short arm of chromosome 17 is missing. Del17p is associated with abnormalities of a key tumor suppressor gene, TP53, which results in poor response to chemoimmunotherapy and worse treatment outcomes. It occurs in about seven percent of treatment naïve CLL patients, with approximately 20-40 percent of relapsed/refractory patients harboring the mutation.  

About ibrutinib
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called BTK. BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Through these multiple actions, BTK helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a microenvironment necessary for survival.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic le
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SOURCE Pharmacyclics, Inc.
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9. Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
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